For a client of ours – an American company specializing in the production of highly-functional, animal-free protein ingredients – we are searching for a Manufacturing Science and Technology (MSAT) Engineer.

The role: You’ll lead process validation, tech transfer, troubleshooting, and continuous improvement efforts to ensure our proteins are made safely, efficiently, and at scale at our production site (location - Botevgrad).

Responsibilities:

Operational Support & Oversight:

• Act as the hands-on technical lead during production campaigns, proactively resolving issues to ensure smooth, compliant execution
• Monitor and enforce adherence to cGMP and company’s internal quality standards
• Lead root cause investigations for deviations and implement preventive actions (CAPAs)
• Own documentation: author and review MBRs, SOPs, validation protocols, and campaign summaries

Technology Transfer & Process Validation:

• Act as an internal customer of internal process transfers from the company’s R&D teams
• Lead Process Performance Qualification (PPQ) and Continued Process Verification (CPV) at the production site
• Support training, method implementation, and process mapping for new and evolving processes

On-Site Analytical Tasks & Data Analysis:

• Execute method validations, troubleshoot process issues, and support analytical activities
• Implement and maintain Statistical Process Control (SPC) using tools such as JMP or Aveva PI
• Translate analytical data into actionable decisions that improve manufacturing performancе

Continuous Improvement:

• Lead initiatives to reduce cycle time, improve yield, and elevate product quality
• Partner cross-functionally with the company’s Manufacturing, Tech Transfer, and Quality teams to scale new technologies and drive operational efficiency

What you bring:

• Bachelor’s degree in Engineering, Biotech, Chemistry, or related field
• 3+ years of hands-on experience in MSAT, Process Development, or a highly technical manufacturing role
• Deep understanding of cGMP principles and regulatory standards (FDA, EMA)
• Technical expertise in fermentation and downstream processes, including centrifugation, membrane (TFF) filtration, activated carbon, resin, and spray drying
• Experience supporting technology transfer, process validation, and manufacturing/ analytical scale-up
• Industry background in biotechnology, food/beverage, and/or pharmaceutical production
• Fluent in English and Bulgarian
• Willingness and ability to travel

Nice to have:

• Master’s in Biotech, Chemistry, or similar
• Experience in Process Development, Manufacturing Technical Support, Analytical Development, or QC/QA role is a plus

HRme license – 2424/18.12.2017